Regulatory/Legislative News

To ensure compliance with the Sunshine Act, medical device manufacturers have several unique factors to consider due to the nuances and intricacies of medical device development not applicable to manufacturers of drugs, biologicals or suppliers. For example, in many cases, physicians need to test, evaluate and be trained on medical devices before their practice or institution will purchase or use the device, which in some cases is mandated by the U.S. Food and Drug Administration in its device clearance or approval letter. These interactions, which are necessary to ensure the safety and efficacy of the medical device in patients, are all subject to the reporting requirements under the Sunshine Act, eg, education or training; associated educational or training materials; meals, travel and lodging; or honoraria.

The U.S. Food and Drug Administration has approved Eylea for treatment of diabetic macular edema, according to a Regeneron Pharmaceuticals press release.

The U.S. Food and Drug Administration has granted orphan drug designation for a recombinant human nerve growth factor-based treatment.

Nidek has announced that the U.S. Food and Drug Administration has issued 510(k) clearance for the AL-Scan Optical Biometer.

The U.S. Food and Drug Administration has approved Ozurdex for the treatment of diabetic macular edema in certain patients, Allergan announced in a press release.

In an effort to expedite the availability of new medical devices, the FDA’s Center for Devices and Radiological Health has undertaken an independent evaluation of its review process, the agency said in a press release.

Recent innovations in optics, materials and mechanics have spawned innovative IOL technologies that are designed to correct more than the spherical error at distance, traditionally corrected by monofocal IOLs.

As noted in part 1 of this series in the April 25 issue of Ocular Surgery News, the Physician Payments Sunshine Act requires “applicable manufacturers” of drugs, devices, biologicals or medical supplies covered under Medicare, Medicaid or CHIP to report annually to the Centers for Medicare and Medicaid Services, in an electronic format, certain payments or other transfers of value to “covered recipients” — physicians and teaching hospitals. These include, but are not limited to, payments for meals, travel, research, consulting, honoraria, training or education, grants, textbooks, journal reprints and other related items.

With an implementing act issued in September 2013 by the European Commission, the European Union seems to be moving toward more centralized, uniform and transparent regulations concerning the approval of medical devices across member states. The legislative proposal is aimed at ironing out inconsistencies in the current regulatory system to better protect patients from defective products such as PIP breast implants and metal-on-metal hip implants.

To the Editor: